Pharmaceutical drug discovery, development, and access news and insights

WHO Updates HPV Vaccine Guidelines: Shift Toward Single Dose Series

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Following the WHO Strategic Advisory Group of Experts on Immunization (SAGE) earlier this year, the organization released an article updating its human papillomavirus (HPV) vaccine guidelines after...

Lilly Announces Mounjaro’s Weight Loss Success in Recent Clinical Trial

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In an announcement issued earlier this year, Eli Lilly is celebrating the success of Mounjaro in achieving 15.7% weight loss across 72 weeks for obese or overweight adults with type 2 diabetes (T2D)....

Comparing Small Molecule and Biologics Drug Development Challenges

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In recent years, pharmaceutical industry members have identified a boom in the biologic and biosimilar space. Although they only comprise a small part of the pharmaceutical industry, biological drug...

Sleeping Pills Linked to Lower Levels of Alzheimer’s Disease Proteins

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A recent study published in the Annals of Neurology identified a link between sleeping pill use and lowered levels of Alzheimer's disease protein. Protein buildups and plaques identified in...

A Melatonin Study Highlights a Lack of Supplement Regulation

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JAMA recently published a research letter highlighting the lack of supplement regulation by comparing the amount of melatonin and CBD in varying brands of melatonin gummies. The researchers determined...

GSK Secures First FDA Approval for an RSV Vaccine for Older Adults

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Despite valiant efforts by other pharmaceutical companies — namely, Pfizer — GSK has secured its spot in the respiratory syncytial virus (RSV) vaccine market, becoming the first-ever...

FDA Publishes Draft Guidance for Decentralized Clinical Trials

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Yesterday, the FDA published a copy of its draft guidance for decentralized clinical trials, adding to previously issued guidelines. Clinical trial participants may be able to bring trials to their...

How Do NIH Funding Requirements Impact Researcher Demographics?

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An analysis of the impact of the National Institutes of Health (NIH) funding requirements determined that they improve diversity in medical scientist training programs (MSTPs). The data revealed more...

Research Reveals That Forever Chemicals May Be Linked to Weight Gain

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Earlier this month, a study published in Obesity identified a link between weight gain and perfluorinated alkylate substances (PFAS), also known as forever chemicals, independent of dietary habits....

Nearly 1 Million Deaths Annually Are Linked to Antimicrobial Resistance

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A recent report from the World Animal Protection (WAP) revealed that almost one million human deaths globally are linked to antibiotic resistance each year, primarily driven by antimicrobial use in...

Understanding the Pharmaceutical Drug Development Life Cycle

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While the pharmaceutical industry and its stakeholders constantly develop and advance new drugs, products, and treatments, the drug development life cycle always needs new discoveries and additions in...

US Continues to Increase Its Reliance on Chinese Pharma Supply Chain

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According to research from the Atlantic Council, pharmaceutical products have become a valuable part of the United States and China’s trading relationship, growing from 0.6% of the total trade to...

Neutralizing Monoclonal Antibodies for COVID-19 Reduces ED Visits

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On April 24, 2023, researchers published the results of a cohort study analyzing the effect of neutralizing monoclonal antibodies (nMABs) on patients with COVID-19, noting significantly improved...

FDA-Approved Cell Therapy Protects Patients After Stem Cell Transplant

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The FDA recently approved Omisirge (omidubicel-onlv), a new cell therapy meant to protect patients with blood cancer after a stem cell transplant. According to the press release, the treatment can...

Study Links Stimulant Prescription Rates to Teen Drug Misuse

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On April 18, 2023, JAMA Network Open published an article linking stimulant prescription rates for ADGD to teen drug misuse. The study analyzed the medical and nonmedical use of prescription stimulants...

FDA Updates EUA for Bivalent mRNA COVID-19 Vaccines to Simplify Use

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On April 18, 2023, the FDA issued an announcement, updating the emergency use authorization (EUA) for the bivalent mRNA COVID-19 vaccines. Attempting to simplify use for healthcare professionals, the...

FDA Guidance Won’t Recommend Another Booster for Most Individuals

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In a news release published Tuesday, the FDA announced that most individuals who already received a bivalent booster vaccine would not be eligible for another dose. FDA officials said they intend to...

GSK Acquires Bellus Health for $2 Billion

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On Tuesday, GSK announced that it had reached an agreement to acquire Bellus Health Inc. for nearly $2 billion. Bellus, a Canada-based biopharmaceutical company, will provide GSK access to camlipixant,...

Merck Plans to Acquire Prometheus Biosciences in a $10.8 Billion Deal

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On April 16, 2023, Merck announced plans to expand its immunology portfolio by acquiring Prometheus Biosciences, a biotechnology company focused on immune-mediated diseases. The deal, valued at $10.8...

Vertex and CRISPR Submit BLA for Sickle Cell Disease Treatment

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On April 3, 2023, Vertex Pharmaceuticals and CRISPR Therapeutics announced that they submitted Biological License Applications (BLAs) for an investigational treatment using exagamglogene autotemcel...